FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
150529–150552 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 1984
UNILYTE A
K843623 · FKQ
Medical Enterprises, Ltd.
Gastroenterology & Urology · 87d
Cleared Nov 16, 1984
FOAM CARE ONE STEP PREP
K843636 · GEC
Ballard Medical Products
General & Plastic Surgery · 60d
Cleared Nov 16, 1984
STORZ ASPIRATION MACHINE SAM 5000
K843644 · BTA
Storz Instrument Co.
General & Plastic Surgery · 60d
Cleared Nov 16, 1984
TRANQUILITY
K843869 · EYQ
Principle Business Ent.
Gastroenterology & Urology · 45d
Cleared Nov 16, 1984
PERSONAL AMPLIFIER SILENCER
K843980 · ESD
Electone, Inc.
Ear, Nose, Throat · 36d
Cleared Nov 16, 1984
SCD STERILE CONNECTION DEVICE
K844144 · FKX
E.I. Dupont DE Nemours & Co., Inc.
Gastroenterology & Urology · 24d
Cleared Nov 15, 1984
INTERMEDICS/GRASEBY DYNAMICS MS 36
K843331 · FRN
Intermedics, Inc.
General Hospital · 80d
Cleared Nov 15, 1984
ARGYLE SILICONE CENTRAL VENOUS CATH-
K843450 · LJS
Sherwood Medical Co.
General Hospital · 71d
Cleared Nov 15, 1984
OHMEDA PEEP VALVE FOR GMS ABSORBER
K843835 · BYE
Ohmeda Medical
Anesthesiology · 45d
Cleared Nov 15, 1984
TITANIUM HIP 1019
K843909 · JDI
Depuy, Inc.
Orthopedic · 43d
Cleared Nov 15, 1984
ANAESLOCK THREE VAPORIZER INTERLOCK HVA003
K843993 · CAD
Southmedic, Inc.
Anesthesiology · 35d
Cleared Nov 15, 1984
AMBU RUBEN CIRCLE ANESTHESIA SYSTEM
K844149 · CAI
Ambu, Inc.
Anesthesiology · 22d
Cleared Nov 14, 1984
CRYO MASSAGE CUP
K843203
Cryo Therapy
Physical Medicine · 92d
Cleared Nov 14, 1984
AGGLUTINATION TEST FOR TOTAL IGE
K843369 · DGC
Scientific Research
Immunology · 78d
Cleared Nov 14, 1984
KANIEVSKI SENSORY AID OR DEVICE
K843433 · LRA
Spectro Industries, Inc.
Ear, Nose, Throat · 71d
Cleared Nov 14, 1984
MANDIBULATOR JAW POSITIONER
K843705 · DYJ
A Company, Inc.
Dental · 54d
Cleared Nov 14, 1984
VENT-A-CAST
K843780 · LGF
Orthopedic Technology, Inc.
Orthopedic · 49d
Cleared Nov 14, 1984
SIROGNATHOGRAPH
K843951 · NFS
Siemens Medical Solutions USA, Inc.
Dental · 36d
Cleared Nov 14, 1984
LINK ACETABULAR MESH
K844225 · FTM
Waldemar Link GmbH & Co. KG
General & Plastic Surgery · 13d
Cleared Nov 13, 1984
N-CHANNEL
K834212 · LOS
Philips Medical Systems (Cleveland),...
Cardiovascular · 344d
Cleared Nov 13, 1984
CANNULA INTRODUCER
K843118 · DYB
Cardiovascular Research, Inc.
Cardiovascular · 97d
Cleared Nov 13, 1984
COULTER COUNTER MODEL ZM
K843164 · GKL
Coulter Electronics, Inc.
Hematology · 92d
Cleared Nov 13, 1984
TRI-MED 610 CAPNOSTAT GAS ANALYZER
K843285 · CCK
Tri-Med, Inc.
Anesthesiology · 84d
Cleared Nov 13, 1984
DELTANODE, MEGA DELTA, DELTA LINK-
K843558 · IYX
Computer Design & Applications, Inc.
Radiology · 64d